Coronavirus

Journeyman

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You can say that again:


It's vitally important that we have faith in the drug approval process so these claims should be investigated by the US FDA and any problems addressed.

However, to put it in perspective, the article you linked to states:

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres.

[Emphasis mine]

So the Pfizer clinical trial involved around 44,000 participants, across many different sites, using different companies and academic centres. This article refers to one company and a cohort of 1,000 participants (and, quite possibly, the issues didn't involve all of those 1,000 participants).

Furthermore, there is no evidence of falsified data in the trials. The claim is that procedures were sloppy for part of the trial consisting of (at most) 1,000 patients. It also seems that Pfizer subsequently conducted an audit of Ventavia, the company in question.

It's possible, but not known, that the poor procedures resulted in incorrect trial results for Ventavia's cohort of participants but unless further quality issues are found, the data at risk only represents 2% of the total trial data.
 

Dropbear

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Pimpernel Smith

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It's vitally important that we have faith in the drug approval process so these claims should be investigated by the US FDA and any problems addressed.

However, to put it in perspective, the article you linked to states:



[Emphasis mine]

So the Pfizer clinical trial involved around 44,000 participants, across many different sites, using different companies and academic centres. This article refers to one company and a cohort of 1,000 participants (and, quite possibly, the issues didn't involve all of those 1,000 participants).

Furthermore, there is no evidence of falsified data in the trials. The claim is that procedures were sloppy for part of the trial consisting of (at most) 1,000 patients. It also seems that Pfizer subsequently conducted an audit of Ventavia, the company in question.

It's possible, but not known, that the poor procedures resulted in incorrect trial results for Ventavia's cohort of participants but unless further quality issues are found, the data at risk only represents 2% of the total trial data.
It's indicative of poor sub-contractor control and management by Pfizer. A subsequent audit by Pfizer is reactive. It's a system failure that gives evidence into the culture of Pfizer and their subcontractors. The emission of data and less than ethical and professional practice is more than worrisome, if Pfizer can't control their subcontractors, even one of them, in a sector that should have extremely stringent tolerances then that's a breach of trust and much worse. And for that reason I'm out.

The FDA are accused of being cavalier and a rubber stamp agency, of which there are many.
 
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Journeyman

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And for that reason I'm out.

To be frank, I strongly suspect you were out anyway, and you're simply using this to retrospectively justify your decision.

1,000 out of 44,000 is 2% - the statistical margin of error in studies is typically about that size, in any case. Even if you exclude those 1,000 from the study, that still leave 43,000 participants, which I understand is larger than most medical trials.

Of course, the sheer number of actual vaccine doses now delivered to people massively dwarfs the doses given in the study. Some 253,000,000 doses of Pfizer have now been administered in the United States alone, with extremely low rates of adverse reactions (apart from the usual headache, tiredness etc for a few hours to a day, which indicates that your immune system is responding).

According to reports I have read (and I may have mentioned this previously), statistics indicate that a person has something like a 0.0001% probability of being injured (not killed, injured) by a COVID vaccine. To put that in perspective, there's a 0.0003% chance that you can be struck by lightning - so you're three times more likely to be hit by lightning than injured by the COVID vaccine. There's also a 1% chance that you'll be killed in a car accident over your lifetime, so if you're concerned about the risk of injury from the COVID vaccine then I very much hope that you refrain from getting in your car and driving anywhere, as it's clearly too risky for you.
 

Pimpernel Smith

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To be frank, I strongly suspect you were out anyway, and you're simply using this to retrospectively justify your decision.

1,000 out of 44,000 is 2% - the statistical margin of error in studies is typically about that size, in any case. Even if you exclude those 1,000 from the study, that still leave 43,000 participants, which I understand is larger than most medical trials.

Of course, the sheer number of actual vaccine doses now delivered to people massively dwarfs the doses given in the study. Some 253,000,000 doses of Pfizer have now been administered in the United States alone, with extremely low rates of adverse reactions (apart from the usual headache, tiredness etc for a few hours to a day, which indicates that your immune system is responding).

According to reports I have read (and I may have mentioned this previously), statistics indicate that a person has something like a 0.0001% probability of being injured (not killed, injured) by a COVID vaccine. To put that in perspective, there's a 0.0003% chance that you can be struck by lightning - so you're three times more likely to be hit by lightning than injured by the COVID vaccine. There's also a 1% chance that you'll be killed in a car accident over your lifetime, so if you're concerned about the risk of injury from the COVID vaccine then I very much hope that you refrain from getting in your car and driving anywhere, as it's clearly too risky for you.
It's about trust and lack of control of out sourced services, which is likely indicative or a warning of potential repeated problems elsewhere. So for me, at this stage, along with other elements, I'm not planning on getting the Pfizer booster when it becomes available.

The risk of me getting a hospitalized breakthrough Covid case is identified here with the median age of 80.5 years telling me the risk for me is acceptable:

 

Dropbear

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Right now, our priority in beating back the virus is vaccinating the 5-11 group and the unvaccinated hold-outs. However, given the waning efficacy of all vaccines over time - boosters will be a more significant tool in the fight at some point next year, when people’s initial vaccine isn’t protecting them anymore.


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Pimpernel Smith

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Right now, our priority in beating back the virus is vaccinating the 5-11 group and the unvaccinated hold-outs. However, given the waning efficacy of all vaccines over time - boosters will be a more significant tool in the fight at some point next year, when people’s initial vaccine isn’t protecting them anymore.
Seem to remember a report stating that US kids in the 5-11 group had already had 41% with natural immunity. Possibly over 50% now.

This seems to be moving into an endless paper chase. The vaccines work, no they don't, or do they? Record number of cases in the Netherlands with a high vaccine uptake. One day it's reported new hospital cases mainly ''young'' people, then over seventies who are double jabbed. Which one is it? When the non-vaccinated need to be protected from the vaccinated, you know there's something either deadly wrong, or spin and mischief is in the reporting. Totally mismanaged.

And yet, I've not seen anything to challenge the mean age of serious hospitalizations and deaths. Utterly bizarre.
 

güero

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According to reports I have read (and I may have mentioned this previously), statistics indicate that a person has something like a 0.0001% probability of being injured (not killed, injured) by a COVID vaccine. To put that in perspective, there's a 0.0003% chance that you can be struck by lightning - so you're three times more likely to be hit by lightning than injured by the COVID vaccine. There's also a 1% chance that you'll be killed in a car accident over your lifetime, so if you're concerned about the risk of injury from the COVID vaccine then I very much hope that you refrain from getting in your car and driving anywhere, as it's clearly too risky for you.
I believe that for most people the probability of being "injured" by COVID (not the vaccine) is multiple lightning strikes away as well, so I don't see how that is supposed to convince the vast majority of the population to get vaccinated.
 

Rambo

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It's about trust and lack of control of out sourced services, which is likely indicative or a warning of potential repeated problems elsewhere.
Ah so then I’m sure you’re going to join me in completely nationalizing all vaccine manufacturing and research so that all studies and ingredients are publicly known and available.
 

Fwiffo

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Ah so then I’m sure you’re going to join me in completely nationalizing all vaccine manufacturing and research so that all studies and ingredients are publicly known and available.

That's not me. I wanted one of every brand. But only one.
 

Pimpernel Smith

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Ah so then I’m sure you’re going to join me in completely nationalizing all vaccine manufacturing and research so that all studies and ingredients are publicly known and available.
You need some control of certain strategic resources and you want medical treatments and medicines as cheap as possible, whilst maintaining enough financial rewards to ensure research and development.
 

Rambo

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You need some control of certain strategic resources and you want medical treatments and medicines as cheap as possible, whilst maintaining enough financial rewards to ensure research and development.
No, no you don’t. We literally subsidize ALL medical research.
 

Pimpernel Smith

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I believe that for most people the probability of being "injured" by COVID (not the vaccine) is multiple lightning strikes away as well, so I don't see how that is supposed to convince the vast majority of the population to get vaccinated.
As Bill Gates has said, the vaccines only last 3-6 months, provide a modicum protection against serious illness, only slightly stop viral transmission and in his own words: ''We need a new way to do the vaccines'' i.e. to block transmission.

So the glorious emergency use experiment with 95-96% efficacy has been exposed as fuckwhittery.

After the 5-11 years old have been double-jabbed and we'll be chasing everyone else for the third-fourth-fifth jabs, will we start with the under 5's in a desperate attempt to frame the narrative that herd immunity can only be reached with constant jabbing of 100% of the population.

We need to manage this with therapeutics as clearly the vaccines are not the panacea we were promised.
 

Pimpernel Smith

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Not sure the Dutch co-worker here is going to make it back before things start shutting at 1900. Flight is tonight.
The bars and restaurants are doomed with a 7pm curfew.

Told my mob to stay at home for the duration. Working 2 days a week in the office lasted all of a month.

The mask resistance is strong now, in the office building and cafe here I'm one of the few wearing a mask. Same with getting petrol the other day, most customers no mask. Haven't been to a supermarket yet, I expect they'll be more mask compliance there.

My missus wants to book a holiday for next May, way too early to be thinking about that with these vaccines that clearly don't give us the freedom promised.
 

Fwiffo

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PM Boris Johnson:
"I'm seeing the storm clouds gathering over parts of the European continent.

"What I'm saying today is that the urgency of getting that booster jab is more evident than ever.

"If we don't do it fast enough, we can see the potential risks to the state of the pandemic in what's happening in other parts of Europe."

Boosters are your salvation.

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Dropbear

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